An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia

Phase 4

Completed

• Conditions: Friedreich Ataxia
• Interventions: Drug: Bupropion & Placebo; Drug: Placebo & Placebo; Drug: bupropion & Citalopram; Drug: Placebo & Citalopram

• Registration Number: NCT01716221
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The purpose of this study is to document the clinical effects of bupropion and citalopram in a single subject with Friedreich Ataxia.

Detailed Description

This is a double blind study with a single subject to objectively document the clinical effects of bupropion and citalopram in a single patient with Friedreich Ataxia (FA), whose disorder symptoms have improved with the use of these medications.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-29
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2016-03-11
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-27
• Last Update Submitted: 2016-07-27
• Results First Posted: 2016-09-19
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

• Friedreich Ataxia

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Exclusion Criteria

• Unable to provide Informed Consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bupropion & Placebo	Bupropion & Placebo	100mg Bupropion \& Placebo taken orally one time per day or 50mg Bupropion \& Placebo taken orally one time per day
Placebo & Placebo	Placebo & Placebo	Placebo \& Placebo taken orally one time per day
Bupropion & Citalopram	bupropion & Citalopram	100mg Bupropion \& 20mg Citalopram taken orally one time per day or 100mg Bupropion \& 10mg Citalopram taken orally one time per day or 50mg Bupropion \& 20mg Citalopram taken orally one time per day 0r 50mg Bupropion \& 10mg Citalopram taken orally one time per day
Placebo & Citalopram	Placebo & Citalopram	Placebo \& 20mg Citalopram taken orally one time per day or Placebo \& 10mg Citalopram taken orally one time per day

Primary Outcome Measures

Name	Time	Method
International Cooperative Ataxia Rating Scale (ICARS)	Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion)	The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease.
Friedreich Ataxia Rating Scale (FARS)	Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)	A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease.

Secondary Outcome Measures

Name	Time	Method
Comparison of FARS and ICARS	Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)	Differences between FARS - ICARS at each treatment interval